Interactive testing system for analysing biological samples

ABSTRACT

The invention relates to a system and a method for health monitoring service based on a central server. Measurements of biological samples (e.g. blood, saliva and urine) are carried out by a remote measurement system. The measurement data are sent to a central server, where the data are processed and analyzed, for example by expert knowledge systems, and a health profile generated is sent back to the remote measurement system. A health care provider may receive the results of the analysis carried out by the expert knowledge system, and the health care provider may further upload laboratory measurements, which can be included in the health analysis of the person. It is preferred that the system and method according to the invention is capable of providing an early warning of diseases that causes changes in chemical components in the biological sample.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.12/377,611 filed Jun. 4, 2009, which is a 371 of PCT/DK2007/050106 filedAug. 15, 2007, which claims the benefit of U.S. Provisional Application60/822,549 filed Aug. 16, 2006, and Danish Patent Application PA 200601067 filed Aug. 16, 2006.

FIELD OF THE INVENTION

The present invention relates to a system and a method for healthmonitoring service based on a central server. Measurements of biologicalsamples (e.g. blood, saliva and urine) are carried out by a remotemeasurement system. The measurement data are sent to a central server,where the data are processed and analyzed, for example by expertknowledge systems, and a health profile generated is sent back to theremote measurement system. A health care provider may receive theresults of the analysis carried out by the expert knowledge system. Thehealth care provider may upload laboratory measurements, which can beincluded in the health analysis of the person. It is preferred that thesystem and method according to the invention is capable of providing anearly warning of diseases that causes changes in chemical components inthe biological sample.

All patent and non-patent references cited in the application, or in thepresent application, are also hereby incorporated by reference in theirentirety.

BACKGROUND OF THE INVENTION

Most countries in the world are experiencing great difficultiesconcerning the hospital expenses. More and more types of illnesses canbe treated. Sickness that was impossible to treat last year may bepossible to treat now due to more advanced equipments. The pressure onhospitals is creating huge economic and political problems in manycountries. The best way to reduce the pressure on hospitals is to reducethe number people that need hospital treatments. New technologiesprovide with new opportunities in assisting family doctors, medicallaboratories and health centres in providing with the health care. Thekey issue is prevention.

The use of the Internet has provided means for forwarding measurementresults from remote locations to central hospitals and other health careproviders, i.e. telemedicine or medical telecommunication. Prior artshows several systems where one or another parameter may be measuredremotely and the result being forwarded to a central for storage andoptionally for forwarding to other interested parties.

U.S. Pat. No. 6,190,313 (Hinkle) discloses for example a system forremotely monitoring the health of a patient to inform the patient as tohis/her state of heath by peak expiratory flow measurements. The dataobtained from the patient is analysed at the patient's site, and thepatient is notified when an indication for a significant change inhealth status is found and may instruct the patient to contact thehealth care provider. Online communication between the remote system anda system at the health care provider is described, as well as a centraldatabase for storing information. The health care provider may receiveinformation directly from the remote system or via the central database.

U.S. Pat. No. 6,278,999 (Knapp) discloses a system for personal localhealth digitizers, for example for determination of ovulation time, anda centralised database that collects and stores monitoring data from alarge number of individuals. The information obtained locally may bepartly processed locally to provide the user with initial information.Physicians connected to the system are allowed to receive informationfrom the centralised database if authorised by the user.

U.S. Pat. No. 6,937,323 (Worthington et al.) discloses a system forchemical and biological testing using a specially designed bio-disc andoptical reader attached to a computer. The system may be located at ahealth center or at the user's private house. Test data are processedremotely and the processed data are forwarded to a central dataprocessing unit connected to the computer through a network foranalysis, wherein the analysis include trending and multivariateanalysis.

U.S. Pat. No. 6,192,320 (Margrey et al.) discloses an interactivemulti-station medical specimen analysis for analysing medical specimensat remote locations and forwarding through a network for evaluating theresults of each of the analyses to a central laboratory. Immediateanalyses are provided at the remote station to inform the user of themeasurement results, whereas trend analyses may be conducted centrally.

U.S. Pat. No. 6,844,149 (Goldman) discloses a system for remotely sampletreatment, wherein the sample is arranged on a multi-component strip andchemical components of the blood are detected. The measurement data maybe processed locally or at a central unit via a network, such as theinterne. Results are be forwarded to a health care provider.

U.S. Pat. No. 6,963,907 (McBride et al.) discloses a system for remotelymonitoring a physical parameter, e.g. cardiac function, by positioning asensor on the individual to be tested. Test measurement data areforwarded via the Internet to a central server having a database foreach individual for processing and analysis, including trend analysis,of the data. The database is used to generate a medical life history andtrend reporting for each individual. The results of the analyses may bedownloaded to the individual and/or the selected physician.

There is a basic need for a service, which can inform of the basichealth parameters and provide with an early warning within differenttypes of diseases. Hospitals all over the world are having troubles dueto increased number of patients and improved techniques to cure people.If hospitals could receive early warnings concerning these diseases, notonly considerable reduction in treatment time is possible, but also muchimproved chances of recovery for the patients.

SUMMARY OF THE INVENTION

The present invention relates to a central server based interactivetesting system, which receives remote measurements of a biologicalsample, and carries out health analysis of the person in question. Theremote measurement system receives a health profile showing the valuesof principal components of the biological sample and how they arelocated relatively to a normal population. The results of the healthanalysis may be communicated to the health care provider in medicalterms. The health care provider may upload further measurements, whichcan be included in the analysis.

Thus, the aim of the present invention is to provide intelligentenvironments for health promotion and prevention or diseases anddisorders. This is obtained by establishing advanced communication anddata based service within the health community. Accordingly, in oneaspect the invention relates to an interactive testing system foranalysing biological samples, said system comprising

-   -   one or more remote measurement system(s) for measuring a        biological sample, said remote measurement system generating        measurement data from the measurement of said biological sample,    -   a central server for processing said measurement data thereby        generating measurement values and/or measurement profiles,    -   means for allowing said remote measurement instrument to        communicate with the central server over a network,    -   in said remote measurement system means for forwarding        measurement data from the remote measurement system to the        central server through the network, and a display unit,    -   in said central server means for generating a health profile        from said measurement values, means for storing said measurement        values, and means forwarding said measurement values and said        health profile from said central server to the display unit in        the remote system.

In another aspect the invention relates to an interactive testing methodfor analysing biological samples, said method comprising

-   -   establishing one or more remote measurement system(s) for        measuring a biological sample, said remote measurement system        generating measurement data from the measurement of said        biological sample,    -   performing a measurement using said remote measurement system        obtaining measurement data,    -   forwarding the measurement data to a central server for        processing said measurement data thereby generating measurement        values and/or profiles,    -   generating, in said central server, a health profile from said        measurement values, means for storing said measurement values,        and    -   forwarding said health profile from said central server to the        remote system, and    -   displaying the health profile.

In one embodiment the interactive testing system comprises decisionsupport for the health care provider by

-   -   determination of the chemical components of a biological sample,        from said remote measurement system, and means for forwarding        the values to the said health care provider,    -   a central server for statistical analysis of the chemical        components and thereby generating health report,    -   means for allowing said health report to forward to the said        health care provider over a network,    -   means for said health care provider to upload laboratory data        and means for including those into the general health analysis,    -   in said central server means for generating a health analysis        reports from said chemical components and possibly laboratory        data, means for storing said reports, and means for forwarding        said reports to said health care provider.

The central server will typically contain a very large database thatcovers numerous types of normal situations and of diseases anddisorders. A new sample from an instrument is in general compared in twoways. The first one is comparison to standard population in thedatabase. The result is a health profile of the person compared to thenormal population we want to compare with (e.g., age, weight or othermeasures). It reflects the required analysis. The report may furthermoreshow the development of the health profile in time. The second one is acheck of numerous different situations. There can be checked fornumerous different situations, which can be of importance for the personand depending on the type of measurements provided. Standard analysiswill typically be to check for indicators of diabetes 2, cancer,cardiovascular diseases and different situations of health risks thatcan be localised in these liquids (stress, infection, sugar level, fatvalues etc). The health analysis may preferably be returned withinseconds to the person. The results of the analysis are, if this ischosen, forwarded to the doctor. It is important to emphasize that theaim of the service is not necessarily to provide diagnosis of diseasesto the remote user. The purpose of the service is to analyse thebiological samples and inform the person and possible the doctor if ithas been possible to detect some special features of importance for thehealth.

The main issues for the present invention are

-   -   Health profile compared normal population that allow citizens to        be informed of their health such that they can improve their        life-style and prevent illnesses.    -   Screening procedures that go through numerous possible        situations for detecting important changes or trend both in        relation to time and to normal populations.    -   Tools for doctors/nurses at hospitals/health centres for        innovative improvements and learning across fields of medicine.    -   Intelligent environments for patients such that they can        co-operate with their doctor/nurse without being confined to        institutional treatment.    -   Advanced interactive environments for doctors and nurses through        connection with the interactive testing system centre which        contains a large database on best medical practices.    -   Best practice and demonstration actions in regional health care        networks to extend the database on health care.    -   A personalised health care service that meets the individual        need of people.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically shows the structure of the service provided by thesystem according to the invention.

FIG. 2 schematically shows an overall view of the type of servicesdelivered by the present invention.

FIG. 3 shows a schematic development of diseases, which are checked for.

FIG. 4 shows a situation, where there is not connection to the healthcare system.

FIG. 5 shows the normal situation, where there is a connection to ahealth care provider.

FIG. 6 shows the situation where a company uses the service to supervisethe health of staff members. Similar situation is at school insupervising the health of children, old peoples' homes, ship crew,sports club etc. Recommendations are provided.

FIG. 7 shows the situation, where only significant risk is forwardedfurther. Otherwise there is not a connection to a health care provider.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relate to a system and a method for analysis ofhealth of people. It is an object of the invention to provide a systemand a method for servicing users or clients with indications of whethertheir health is within normal ranges or whether it is recommended to seea health care provider for further examination and analysis. This isprovided by a system and a method wherein certain predefined measurementvalues, such as haemoglobin, blood sugar and cholesterol are extractedfrom the raw measurement data and compared to references, and additionthereto fingerprints or patterns of the chemical compounds in thebiological sample are compared to fingerprints or patterns of chemicalcompounds found in individuals suffering from specific diseases. Thus,as opposed to the result for a single component, such as blood sugar, aprofile will normally relate to the pattern of more than one singlecomponent, such as a pattern of several components and their relation toeach other, for example as seen as spectra. In order to generate ameasurement profile it may not be necessary to extract information ofeach component, it is simply enough to compare the spectra withreferences, in that it is not the single component that is analysed butthe total pattern or fingerprint of the components. Thereby it ispossible to issue an early warning of a coming disease if changes in thechemical components point to the onset of a disease. Therefore, thesystem and method according to the invention performs measurements ofseveral chemical components in order to provide the necessary chemicalprofile.

There are three types of ‘clients’ that are expected to use thisservice. First type is individual persons, who want to subscribe to theservice of carrying out the measurements themselves and to receivehealth profiles from the interactive testing system. Some of thesepersons will also subscribe to a service, where a health care providerreceives the health profile from the interactive testing system andevaluates it. The second type is family doctors, health centres, medicallaboratories, hospitals and other institutions that provide health careservice of people. The third type is schools, households, companies,sports clubs and similar ones that want health check for their membersbased on specific measurement instruments. The structure of the serviceis illustrated by the FIG. 1.

The client can choose a health care provider, family doctor, healthcentre, hospital, coach of a sport or some other instance. If the clientchooses that the health profile is to be sent further, that instance isinformed of that it may receive health profile from this client andpossible some analysis. Furthermore, the instance will receiveinstructions of how to use the services of the interactive testingsystem, for instance, how historical data for the client can be viewed,how special statistical analysis can be carried out, how to obtaindecision support for diagnostic purposes, how to add laboratory data tothe client's data and similar instructions such that the services can beutilised effectively.

The measurement instrument is connected to the interactive testingsystem centre through a network, such as the Internet. The interactivetesting system offers different services, when an instrument has beenregistered. The services are of the type:

1. When an instrument has been registered, it can be used to measure thechemical content of the biological tissue, such as liquids blood, urineand saliva. This can be carried out for any person, who has beenregistered at the interactive testing system. When the measurementvalues of the instrument have been sent to the interactive testingsystem, the client will receive information of how the person is locatedrelative to a normal population.

2. The client can ask for monitoring of a special value of some healthrelated parameter in the blood or urine.

3. The measurements of the client can be forwarded to a health careprovider. The health care provider may also receive extensivestatistical analysis of the data. On the basis of this the health careprovider may reply to the interactive testing system. The interactivetesting system forwards it to the client and will store thecommunication.

4. The client can be a patient that has been discharged from a hospital.The service can be used as a remote supervision of the patients. Atregular time intervals the patient carries out the measurements, whichare sent to the hospital. The hospital replies in an email, how thesituation is progressing.

5. The health care provider can provide with supplementary measurementsto the interactive testing system.

6. The interactive testing system can be used for decision support tothe health care provider.

The purpose of the services is to provide with Health Profiles of thepersons that communicate with the interactive testing system. Thus theresults of the analysis are how the measurements are situated comparedto a population that is appropriate to compare with. The service isprovided to everybody that has an instrument registered at theinteractive testing system.

Remote Measurement System and Remote Measurement Instrument

The interactive testing system comprises one or more remote measurementsystems. The remote measurement system generates measurement data fromthe measurement of the biological sample. The remote measurement systemfurthermore communicates either directly or indirectly with the centralserver through a network, preferably the Internet. In the remotemeasurement system a display unit is available for displaying the healthprofile when received from the central server.

The remote measurement system may comprise both a measurement instrumentand the means for forwarding measurement data, i.e. a communication unitintegrated in the system, or the measurement instrument may be separatefrom the communication unit. In the latter case the communication unitmay be a conventional computer and the measurement instrument may beadapted to connect to the computer, for example through a USB port. Themeans for forwarding measurement data may be any conventionalcommunication unit, such as a communication unit in a conventionalpersonal computer for communication on the Internet. Every measurementsystem has a well-defined communication address (for example anIP-address) and are communicating with the interactive testing systemcentre through this address. All communication between the centralserver and measurement system is preferably encrypted for securecommunication.

Measurements can be carried out at any time and by anyone, who has beenauthorised to use the measurement instrument according to the invention.More than one person can use the instrument for measurement purposes.The measurements are carried out on biological samples, preferably bodyfluids, such as blood, saliva and urine.

In either case the measurement instrument is one, which has beenclinically tested to give sufficiently precise measurements of the bodysamples, such as blood, saliva and urine. Through these clinical studiesthere have been established a reference data base, which assists in thestatistical analysis of measurement data. There are many instrumentsthat can be used, which give sufficient precision. An example isappropriately calibrated instruments based on optics, such as NIR, IRand FT-IR instruments, which can be produced cheaply for home usage.

It is preferred that a measurement instrument according to the inventiongives information on molecular level of the chemical components ofblood, urine and saliva, and forwards the raw measurement data to thecentral server for analysis to generate measurement values. Aninstrument may be based on a Near Infra-Red technology, and the datareceived may be interferograms or spectra based on Fourier Transform.For instance it may give 3200 data values for one sample, which has beenmeasured. All data values are sent to the server. In this case3×3200=9600 numerical values may be sent to the central server, if asample of blood, urine and saliva has been measured. At the server theestimate of the chemical components are carried out, preferably usingchemometric methods to estimate the chemical components, therebyobtaining measurement values. Furthermore, analysis of patterns orfingerprints gives rise to measurement profiles.

The measurement instrument preferably can detect changes in the blood,saliva and urine, which the person cannot feel or detect. If the personcarries out the measurements at regular time intervals, it is possibleto detect changes that may lead to diseases. The diseases: “Rheumatism,Cardiovascular diseases, Metabolic disorder, Diabetes 2, Glandulardiseases, Infection diseases, Lung diseases and Cancer diseases” allstart by changes in some chemical components in the blood, which can bedetected at an early stage. Thus the service can be used to provide withan early warning within each of these types of diseases.

The chemical components in the morning are for a normal personrelatively constant. The caffeine from the coffee drinking the previousday has disappeared from the blood. Similarly, at normal alcoholconsumption the alcohol in the blood has disappeared from the blood.Adrenaline due to tense situation previous day has disappeared. Thus, ifa person is measured in the morning, the results of the chemicalcomponents in blood, saliva and urine will be relatively constant.

If a person is measured early morning once a week over 10 weeks, it willbe possible to define the ‘fingerprint’ of chemical components, which isnatural for the person. Furthermore, such “fingerprint” of chemicalcomponents is normally individual, so that each individual “fingerprint”differs from fingerprints from other individuals. It is recommended tocarry out each measurement twice over these 10 weeks period in order todetect the variation in data values due to the measurement situation.Thus, after a 10-week period it is possible to determine the levels ofthe chemical components, which are natural for the person, and the typeof variation that may be expected from day to day.

In a preferred embodiment the person, who has acquired a measurementinstrument according to the invention, and carried out the 10 weeksmeasurement plan, has established a safety line to the central server.The safety line can be used as a service to supervise ones own healthcare, or to improve ones health conditions. Persons needing specialdiets can use the service to find an appropriate diet, which fits themwell. A sports person can use it to supervise the parameters related tothe performance within the sports field. It can be used to document thatthe person is not using doping means to achieve performance, althoughthe service does normally not give an official certificate of that theperson has not used doping means.

Health Profile.

The basic service is an on-line service. Based on the analysis of themeasurement data as well as the measurement values generated at thecentral server, the client receives a health profile. If a health careprovider has been connected in respect of the client the health careprovider also receives the results of a standard statistical analysis. Ahealth care provider may require a special health profile for a client.For example a person, who has been diagnosed as belonging to a Diabetes2 risk group, may receive a special health profile that assists theclient in supervising his/hers health.

The criteria that are used in designing this service are preferably‘direct, simple and robust’. By ‘direct’ it means that the analysisleads to information of whether the situation is normal or not. That allof the standard analyses are simple and robust means that they can becarried out for all, and the results are easily communicated to a healthcare provider. A more detailed analysis can be asked for by the clientor the health care provider. The health care provider can use theservices of central server to identify the analysis that he/she wants tobe carried out.

At the central server an analysis of the incoming measurement data ofthe biological sample is carried out. The chemical components of thesample are computed to generate measurement values and/or profiles and ahealth profile is generated based on the measurement values. The remotemeasurement system receives the health profile, which in a preferredembodiment shows how the basic health parameters of the person arelocated relatively to a normal population of corresponding age, sex etc.The health profile may be presented as a table of data values showingthe present measurement values of the parameters and optionally a graphshowing the last 10 measurement values of the parameters. The graph mayshow the historical developments of the measurement values. The healthprofile may for example include information of for instance,cholesterol, blood percentage, total protein, sodium, potassium, fatcontent, sugar level in blood, urine and saliva, depending on what wasmeasured.

Furthermore, at the central server, further analysis of the rawmeasurement data may be performed. This includes processing of the rawmeasurement data into fingerprints or patterns for comparison withreferences for one or more diseases.

Based on the measurement values as well as on the result of analysis ofthe profiles, the health profile may contain further information. In oneembodiment the remote measurement system may receive one of severaltypes of comments to the analysis that has been carried out. It may bepointed out that no special features have been found. Secondly, thatsome special features have been found and it is recommended to carry outmore frequent measurements than what has been done previously in orderto be able to carry out necessary or appropriate analysis. The thirdtype of comments is that some significant features have been found, andit is recommended to contact a health practitioner. A fourth type ofcomments is that transmission of a recommendation of following theadvice of a health care provider. Such advice may either be generatedbased on the actual health profile or have been generated before andjust reiterated.

In a preferred embodiment, when a client has carried out a measurement,and all measurement values from the instrument are sent to the centralserver, the client will preferably within a minute or so receive thehealth profile.

Preferably the health profile contains the following information:

1. A data table showing the values of some chemical components in theblood sample, and how these values are related to a normal population.

2. A graph showing the historical values of these parameters (optionalup to last 30 measurements)

3. Comments on the results of analysis. The results are presented eitherthat nothing was found or recommendation to contact the health careprovider.

In general, as stated above, the client will preferably receive ananswer within a minute or so of the basic health parameters after thedata have been sent to the central server. But at the server extensivestatistical analysis may be carried out on the new measurement data andthe available historical data. In a preferred embodiment intensiveanalysis is carried out for each of the eight areas:

-   -   Rheumatism    -   Cardiovascular diseases    -   Metabolic disorder    -   Diabetes 2    -   Glandular diseases    -   Infection diseases    -   Lung diseases    -   Cancer diseases

If some special features are found, the client may later receive a newmessage, which recommends contacting the health care provider.

Health profiles may be different depending on what has been asked for.When people subscribe on the service, they may ask for a generalanalysis of the blood and urine. In this case the basic parameters ofblood and urine are communicated back to the client. Furthermore, theclient receives a short review of the historical values or values oversome appropriate time periods. If a trend has been detected, forecastsfor the next three periods are presented as a standard. Limits that arenormal for the population are presented. The limits are to be understoodthat 99% of the population, which the client is compared to, may beexpected to be within these limits.

Furthermore, if a health care provider is connected to the centralserver, the system may further include means for allowing the healthcare provider to provide recommendations to be included in the healthprofile forwarded to the remote system.

Central Server

The central server processes the raw measurement data provided by theremote measurement system as well as generates measurement values fromthe processed measurement data. Furthermore, the central servercomprises means for storing the measurement values, in a preferredembodiment both storing actual and historical values as well as normalpopulation ranges for references. In a preferred embodiment there aretwo databases at the central server. The first one has been developed byclinical study using the given measurement instrument according to theinvention. It contains reference values for the each of the diseases,which has been clinically studied in relation to the measurementinstrument. The other database contains measurement values that havebeen carried out remotely and received by the server.

Preferably, as a standard three types of analysis are carried out. Thefirst is an analysis aiming at detecting if there is a trend in data. Ifthere is a trend in some of the parameters, forecasts are made and theresults are evaluated in the light of the forecasts. The second type ofanalysis has the purpose to find out if there have occurred significantchanges in the basic parameters over recent period. The purpose of thisanalysis is to find out if parameters are normal, or if there isdeveloping a pattern that may influence on the health of the client. Thethird type of analysis if there are patterns in data that point to risksin one or more of the types of diseases in focus at the interactivetesting system. The results of this analysis are reported back to theclient in a way that the client is recommended to see a doctor, ifsignificant risks have been found. A health care provider may furtherreceive the results of analysis and explanation of the patterns found.However, preferably no specific diagnoses are reported to the remoteuser.

Preferably an expert knowledge system is used to evaluate the incomingmeasurement data. There are two types of evaluations carried out. Onetype is using chemometric methods to evaluate how new measurements arelocated geometrically in the light of the clinical database. The othertype is the use of Neural Nets to identify if the present values matchthe measurement profiles, which have been developed, using Neural Nets,from the clinical database. Risk evaluation is based on both types ofmethods. If both agree that there is significant risk of a disease, anearly warning is issued. There is preferably an expert knowledge systemfor each illness, which is considered from the eight types of diseases.

The statistical analysis consists of two parts:

-   -   a) Specially developed chemometric methods are used to identify        chemical components in the biological sample, such as blood,        urine and saliva. Furthermore, the developed methods are used        try to identify special ‘profiles’ in data, which the clinical        studies have suggested may be relevant for detecting early        stages of the diseases. The results of this part of analysis are        sizes of chemical components in blood, urine and saliva, which        may be of importance for the diseases in question, and study of        these in relation to the clinically tested data.    -   b) Each type of disease has a specially developed pattern        recognition method based on Neural Nets. These pattern        recognition methods are developed on the basis of the clinical        data and with the assistance of clinical experts. The resulting        expert knowledge system reflects the knowledge and procedures of        the medical experts. When a client is studied, the knowledge        system receives input from the chemometric methods. At first a        client has zero chances of belonging to the risk group of this        disease. When more and more measurements arrive the odds for        this disease may increase. When significant risk has been        detected, the client may be asked to carry out measurements at        some specific time intervals, e.g. weekly. In this case also the        health care provider is informed of the results found.

These two types of analysis are carried out for diseases consideredhere. For instance, different types of cancer are studied. As anexample, evidence against colon cancer is studied. In the clinicaldatabase there are detailed measurements of a number of patients thathave been diagnosed by colon cancer. The chemometric methods analysechemical components and special measurement ‘profiles’ in data (e.g.increased production of proteins in the blood and increased amount ofproteins in the urine), which are frequent for colon cancer. Thespecific expert knowledge system used here has been developed with theassistance of medical experts in the field. Evidence is accumulated foreach client until a possible significant result is found, in which casethe health care provider is informed and results presented. Theinformation provided is given in the terms that the medical expertsspecified for giving evidence of colon cancer.

For each client possibilities of different types of illnesses withineach of these eight groups of diseases are studied. One collection ofchemometric methods are used for each type of illness. Furthermore, oneset of expert knowledge system is used for each. The type of chemometricanalysis and knowledge system differs from illness to illness. Each setof tools have been developed to provide the medical expert of theillness with appropriate information for decision support.

Furthermore, the central server comprises means for communicating withthe one or more remote measurement systems in order to forwardmeasurement values and health profiles to the client.

Communication with Health Care Providers and Others

The basic interactive testing system includes the remote user, i.e. theclient, and the central server, and communication is conducted betweenthese two entities. However, it will often be relevant to include otherentities in the communication flow in order to optimise the preventionand/or monitoring of diseases.

First of all, the interactive testing system may provide means forenabling a health care provider to communicate with the central server.In the most basic form, an assigned health care provider receives thehealth profile generated for the remote user according to someagreements, which have been signed and confirmed. The agreement may bethat the health care provider receives a report each time measurementsare carried out, at some specific time intervals, only if significantresults have been found or according to some other contract. Theinteractive testing system will not provide with a direct diagnosis. Butif a person has been measuring himself/herself over a period of time,the advanced methods of pattern recognition at the interactive testingsystem will detect an early stage of a disease. The health care providerwill get the results of the analysis, and will be able to use it as adecision support.

Additionally, it may be preferred if the health care provider can uploadlaboratory measurements for the client, for these new sets of data to beincluded in the statistical analysis. The health care provider canrequire a medical report with and without the new laboratory data.

Furthermore, the health care provider may, in addition to or instead ofthe health profile, receive or request to receive an expert report basedon analysis of the measurement values and/or measurement profiles. Forexample a clinical database in the central server may suggest that somechemical components in blood, urine and saliva should be estimated andanalysed. The expert knowledge systems may then suggest possibleevidence of the illnesses that are being detected and communicate theresults in medical terms. For example, if one of the expert knowledgesystems has detected a significant risk of an illness, a report isprepared, which expresses in medical terms the results found. The reportwill reflect the procedures, which the clinical doctor would use in theevaluation of the present measurement values and the report could beused as a support for the decision of the clinical doctor. The reportcan, besides medical information, contain recommendation concerninglifestyle. The report may be forwarded to instances that have beenagreed upon.

Other entities authorised to receive reports from the central server maybe patient unions. There may be an agreement of that a patient unionwill receive a report, if significant development has been detected. Forinstance, there may be an agreement that the union of diabetes patientsmay receive the report, if there has been detected a significant risk ofdiabetes 2. Such a report may be identical to the health care reportforwarded to the remote user, or more specific or more general.

In a preferred embodiment the person responsible for the measurementinstrument according to the invention owns the data that have been sentby the measurement instrument. The person can at any time logon theserver and delete part or all of the data that have been received fromthe instrument. Furthermore, the owner of a measurement instrumentaccording to the invention can at any time log-on the server and viewthe historical development of some health parameters. The healthparameters viewed can be different from the ones that are received, whenmeasurements are carried out.

If authorised, other entities, in particular a health care provider, maybe able to logon the server and view the historical development of somehealth parameters.

Remote User

The remote user, or client, is normally the individual to be tested.However, there can be an agreement that for instance a hospital can sendmeasurement data from a measurement instrument according to theinvention to the server with the purpose of analysing the data. Thehospital/health practitioner will receive the results of analysis. Thedata may be values from a measurement instrument according to theinvention supplemented by laboratory measurements. The numerical valuesthat have been analysed may or may not be stored in the database at theserver.

The remote user can subscribe on the service that the interactivetesting system provides with in two ways. The subscription can concernreceiving health profile only, or it may also include a health careprovider.

-   I. A client registers for health profile. The client can buy or rent    a measurement instrument, which for example can measure the chemical    content of blood, urine and saliva. When the client has carried out    the measurement, the data are automatically sent to the interactive    testing system, and the client receives back a health profile as    described above. The measurements are stored in a database at the    central server, and the client can at any time carry out these    measurement, retrieve measured values and the historical development    of the health parameters. The client may allow for allocation of    other entities to communicate with the central server relating to    his or her data.-   II. A client registers for a communication service with a health    care provider. A client can register for communication with a health    care provider (family doctor, health centre, hospital etc). At this    registration the client specifies the degree of service, which the    health care provider is giving. When a client is registered for this    service, the measurement values and/or measurement profiles are    forwarded to the health provider. The health care provider answers    back to the interactive testing system, which sends it back to the    client. This communication is stored at the interactive testing    system for later reference. The client can agree with the health    care provider that further data and information can be stored at the    interactive testing system.

When a health care provider is involved in the service, he/she canutilise the different services that are made available at theinteractive testing system, like advanced statistical analysis, decisionsupport, on-line services etc.

FIG. 2 gives an overall view on the type of services delivered by thepresent invention.

A review of the services is as follows:

1. Family doctor. A family doctor has an approved instrument to measuree.g., blood, urine and saliva. The measurements can be checked againstthe data base at the interactive testing system and provide with healthprofile for the person. The doctor can utilize the services offered atthe interactive testing system in different ways to improve the healthcare task.

2. Health centre. At a health centre there are certain instruments thatcan measure beside the chemical contents of blood, urine and saliva,also e.g., heart function and blood pressure. The data can be sent tothe interactive testing system for investigation.

3. School. A school has an instrument to measure blood and urine. Thedata can be checked at the interactive testing system and return ahealth profile for each pupil at the school.

4. Patients. A patient sends regularly their data that they havemeasured themselves. The interactive testing system centre carries outthe monitoring and supervision of their health status, and sends theresults to the doctor/hospital in question. The answer from thedoctor/hospital is sent back to the patient.

5. Hospital. A hospital establishes a database of health data that issupervised and updated by the interactive testing system. The hospitaluses the database for its own analysis of health and diagnosis that isassociated with these measurements. This means that the database isstored at the hospital instead of at the interactive testing system. Theinteractive testing system only carries out the analysis.

6. Sports club. A sports club, like e.g. a golf club, provides with aservice to their members that they can be measured and data analysed atthe interactive testing system. There may or may not be a doctor thatreceives the results of the measurements.

7. Company. A company can provide with a standard analysis of the healthof the staff. The health questions that the company can subscribe on canbe a) recent use of drugs, b) extensive use of alcohol, c) generalhealth condition, and others.

8. Population. A population can be checked for special symptoms likee.g., diabetic 2.

9. Athletes. Athletes can subscribe on the service that they deliversamples of blood and urine and they receive health profiles that showthat they are clean with respect to a given collection of drugs. This isnot a certificate of not using drugs, but over time documents no usageof drugs.

10. Union. A union of people, like e.g., labour union, private clubs orassociations, can provide a service to its members that they can obtainat regular time intervals a check of their health by the service of theinteractive testing system.

11. Society. The people of a society like e.g., a village with access toInternet can be offered the service that they can be supervised by theinteractive testing system using the measurement instrument in thevillage.

12. Household/Individual. A household or an individual can choose toinvest in a simple measurement instrument that can be connected to theinteractive testing system through Internet, and subscribe on a healthprofile service from the interactive testing system.

Furthermore, the interactive testing system according to the inventionmay be used for monitoring individuals suffering from a diagnoseddisease as well as for supervision of patients, elderly and/orhandicapped persons.

The hospitals are often being filled by patients that have finishedtreatment and are only at hospital for monitoring purposes. Thesepatients would be able to be sent home, if they could be supervisedremotely by a nurse or a doctor. E.g., if a patient has been treated forcardiovascular disease, the patient could measure himself/herself andfill out a blanket, which is required by the hospital. The responsiblenurse or doctor could use the analysis carried out at the interactivetesting system as a decision support for further analysis.

Elderly people could be longer at home. If they carry out regularmeasurements, e.g., once a month, the family doctor could follow up onthe measurement analysis, and decide if further analysis is needed inthe light of the analysis from the interactive testing system. In thisway people can come to proper treatment much earlier than if the diseasehave already occurred and then start the medical analysis.

Handicapped people or people that have been diagnosed as belonging to arisk group of one of the above diseases can stay at their homes. Byregularly measuring the person it is possible to supervise the personsand detect, when direct efforts are needed.

Example of Steps in the Interactive Testing System Service

The different steps or aspects of the interactive testing system serviceare presented as follows:

Purchase of a Measurement Instrument According to the Invention

1. A customer buys or rents a measurement instrument (typically smallsized, such as 15×15×10 cm). At the time of purchase there may beassigned a health care provider, who will receive information fromanalysis. Assignment of a health care provider can be done at any time.Different users of the instrument can have assigned different healthcare provider.

2. The customer receives a PIN code, for example by mail.

3. The customer carries out the necessary installation of software tosecure connection to the central server.

4. When the instrument is used the identification is the PIN code and apersonal identification. The identification is the one provided by thecustomer. At later measurements the person is identified by the PIN codeand name.

5. The customer carries out the measurements of blood and/or urineand/or saliva. The instrument (possibly through the computer) sends themeasurement data to the central server. Within a minute or so thecustomer will receive a data sheet, a graph and some short remarksconcerning the findings. The data sheet will show how the person is inproportion to a normal population.

Usage of a Measurement Instrument According to the Invention

1. At first the person is identified. PIN code and name is given. It isalso informed if this is the first time that the person carries out themeasurements. This is important because later measurements are rejected,if it is detected that they do not come from the person specified.

2. The measurement of a sample of blood and/or urine and/or saliva iscarried out. The measurement values of the instrument are sent to thecentral server. Within a minute or so the person will receive the healthreport, for example in the form of a Data Sheet and a Graph.

3. The person can select that some special information should be sentback. Diseases in focus may be: Rheumatism, Cardiovascular diseases,metabolic disorder, Diabetes 2, Glandular diseases, Infection diseases,Lung diseases and Cancer diseases. In agreement with the health careprovider the person can, instead of the standard data sheet, receiveinformation relevant to these diseases.

4. The person will receive a message, which gives an overall answer ofthe results of analysis that have been carried out. If special featureshave been found, there may be recommendation to contact the health careprovider.

5. If there is assigned a health care provider to the person, theresults of analysis can be sent to further to the health care provider.This health care provider will receive a report on the results of theanalysis. There will be the option that also the historical developmentis sent further to the health care provider.

Customer's use of the Data Centre

There are two types of services that are provided, Data Service andAdministrative Service. The person identifies him or herself by a username and password.

Data Service

1. The person fills out a form that specifies which data are wanted tolook at. The person specifies data, period and the way the results arerequired to be displayed.

2. The historical data are shown in the desired way. The person canselect different ways to present the data.

3. The person can choose that specific data are sent further to thehealth care provider, who is assigned to the person.

Administrative Service

1. Concerning payment of the service

2. Assign a health care provider to a person.

3. Delete or remove data from the database of the central server.

4. Problems with the interactive testing system service

5. FAQ's

Health Care Provider Receive Measurement Data

1. Receive present measurements and the historical development for aperson.

2. Receive the results of the analysis of data. It is aimed at that thereport can be used as a decision support for the health care provider.

Use of the Central Server

1. After filling out username and password, a form is presented. This isused to select data from the database for the person in question.

2. It is possible to view historical data in different ways.

3. It is possible view recent decision support that has been suggestedin the past.

Upload Laboratory Data to the Server

1. The health care provider can choose to upload laboratory data thatare available for a person. The type of files follows hospital standardsfor laboratory files.

2. The health care provider can ask for extended analysis based on themeasurements and uploaded data. New extended decision support is madeavailable in the light of the new data.

Examples of Applications of the System and Method According to theInvention Service 1: Comparisons to Normal Population

The user of the interactive testing system service registers on anappropriate form. The information from the form is included in theregistry of clients to the interactive testing system service. Whenmeasurements are carried out, the client specifies the user name andpin-code. This identifies the client. The measurement values arereceived by the interactive testing system and analysed further. Theanalysis is partly based on the present values, historical values and alarge reference database. The client will receive information on thevalues of basic health parameters (e.g., cholesterol, blood percentage,sugar level, fat etc) and how these values are located relative to anormal population. If a detailed statistical study indicates risks ofthe client's health, the person will be recommended to see a doctor. Therisk groups analysed are some types of cancer, diabetes 2, some commoncardiovascular diseases, internal infections, stress indicators andsimilar indicators that indicate risks for the health.

Execution Example 1

A typical example of the service is as follows:

-   -   A client fills out a blanket asking for user name and pin-code.        The user can also fill out information on weight, sex and age.        Measurement of blood and/or urine and/or saliva is carried out.    -   The client receives back information on the basic health        parameters and how they are located relative to normal        population.    -   If special risks have been detected at the interactive testing        system, the client is informed of recommendation to seek a        doctor. Otherwise the client is informed of the no special        features have been found.

Service 2: Monitoring Special Levels of Values

A client can ask for monitoring of special parameters in blood or urine.This can be important for persons that have been diagnosed in some riskgroup. E.g., persons that are in the risk group of diabetes 2 or havebeen diagnosed with diabetes 2 can carry out regular measurements and beinformed of the parameters that are relevant for these groups.

Execution Example 2

A typical example of the service is as follows:

-   -   A person that is severely overweight can ask for monitoring the        fat level in the blood.    -   If some results have been found that are judged special, they        are marked with a comment. In this case there may be        recommendation to contact a doctor.        Service 3: Communication with a Health Care Provider

The interactive testing system can arrange communication to a healthcare provider. When such a communication contact has been established,the results of measurements and associated statistical analysis are sentto the health care provider, who typically would be the family doctor.He/she receives the email from the interactive testing system andanswers the email, which is stored at the interactive testing system andforwarded to the client. The health care provider can, like the client,at any time logon the interactive testing system site and studyhistorical data of the client.

Execution Example 3

A typical example of the service is as follows:

-   -   The client carries out measurements that are sent to the        interactive testing system. The client receives the standard        health profile that was asked for. The measurement values and        the results of analysis are sent to the health care provider.        The health care provider answers the email. It is stored at the        interactive testing system and sent further to the client.    -   This communication is stored at the interactive testing system        and can be viewed at any time by the client and the health care        provider.

Service 4: Supervision of Patients

It happens often that patients are kept at the hospital after treatment,although the treatment has been completed. This is often done as asafety measure. But the present service can be used to release thepatients earlier than normal and instead use this service to supervisethe patients. The patients will be able to measure themselves or by avisiting nurse. The results of measurements, together with a blanketfilled out by the patient or the nurse, can be sent to the interactivetesting system, which analyse the results further and sends the resultsto the hospital. The doctors at the hospital can evaluate the resultsand send the evaluation back to the patient. This can be carried outwhile the visiting nurse is at the patient. If the hospital is ready toanswer, the technology can complete the tasks in few minutes at most.

Execution Example 4

A typical example of the service is as follows:

-   -   The patient at his home, or a nurse, carries out the        measurements. A blanket concerning the body temperature and        other actual information is filled out. The measurements and the        blanket are sent to the interactive testing system that analyse        the data. The measurements, the blanket and the results of        analysis are sent to the hospital. The hospital answers with a        new email to the interactive testing system, which is sent        further to the patient and also stored at the interactive        testing system.    -   The interactive testing system stores the communication between        the patient and the hospital.

This information can be retrieved by the hospital or a health careprovider that is authorised to look at the patient data.

Service 5: Supplementary Laboratory Measurements

A health care provider can in agreement with the client decide to storesupplementary laboratory measurements at the interactive testing system.These new measurements can enter the statistical analysis that theinteractive testing system carries out and thus provide with moredetailed results for the client in question. The client can view thesenew data, and the health care provider can study the historicaldevelopment of all data, both the ones that the client measures and theones that the health care provider supplies.

Execution Example 5

A typical example of the service is as follows:

-   -   The interactive testing system receives the new measurements        from a client. The results are sent to the health care provider,        who suggests that the person should go through some laboratory        tests. When the health care provider receives the laboratory        measurements, they are sent to the interactive testing system        for storage and integration into the interactive testing system        service.    -   The client can view the results of the new laboratory        measurements in the light of the personal data and their        development over time. The health care provider can ask for        diagrams over time of a health profile required analysis.

Service 6: The Use of the Interactive Testing System for DecisionSupport

The interactive testing system provides with a database, where healthcare providers can store different background information. Theinformation stored is what the health care provider considers relevantfor the client in question. The interactive testing system provides withadvanced pattern recognition methods that can assist the health careprovider in making correct decision for the person in question. Thehealth care provider may propose different alternative types of diseasesfor the person. The methods will assign probabilities to each of theproposed diseases. This allows a check for numerous diseases, detectionof trends or symptoms for unbalances that might result in diseases.

Execution Example 6

A typical example of the service is as follows:

-   -   A health care provider has a lot of background information on a        client. The health care provider may want some of this        information to be included in the database of the interactive        testing system for decision support. The health care provider        logs in the interactive testing system's decision support        database. Blankets shown are filled out. Furthermore, diseases        are specified, which are to be analysed. When blankets have been        filled out the health care provider receives probabilities        showing the rating for the different alternatives that have been        specified.    -   The health care provider can provide with further information        and ask for new analysis. The health care provider can ask for        that the analysis is carried out at regular time intervals, and        if a probability exceeds some limit, an email should be sent to        inform of the change in the clients health.

The curve in the FIG. 3 shows typical development of the severity of adisease considered in this invention. The base line indicates the normalsituation for a person. Then there are typically following stages in thedevelopment of the disease.

I Molecular changes in the blood due to the illness can be detected.

II Pre-clinical stage. The changes in the blood can be measured by ameasurement instrument according to the invention.

III The person can feel that something may be wrong. It can be feelingtired in the morning, headache, stomach pain or feeling of somediscomfort. The feeling may disappear by headache pill or coffee.

IV The medical health practitioner can see or feel that something mightbe wrong. If the symptoms can be identified, the patient may be sent toa hospital/specialist for further treatment.

It may be that the medical health practitioner only prescribes aheadache medicine or something similar.

V A hospital treatment starts. It may vary over some time.

VI An irreversible stage. The illness is not curable, when it is beyondthis level.

Illnesses within the following types of diseases are considered:Rheumatism, Cardiovascular diseases, Metabolic disorder, Diabetes 2,Glandular diseases, Infection diseases, Lung diseases and Cancerdiseases

Discussion of FIGS. 4-8 FIG. 4 No Connection to a Health Care Provider

A client carries out measurement using a measurement instrumentaccording to the invention. The client receives back values of theparameters that have been asked for.

Examples

-   -   A sports person measures the blood and asks for the value of        haemoglobin value. He or she may only be interested in the        amount of the red blood corpuscles.    -   A pregnant lady measures blood once a week and only asks for the        value of the blood percentage.    -   A person only measures urine once a month. He or she is only        interested in the amount of sugar in the urine.    -   A person measures saliva once a month. It is used as guidance if        further measurements should be carried out.        FIG. 5. A Normal Situation with a Connection to a Health Care        Provider

A client, a person, carries out measurements that are sent throughInternet to the server. The measurements are analysed. A health profileis returned to the client. A Report is sent to the health care provider.The health care provider may have further data, which can be uploadedand included in the analysis of the Interactive Testing System.

Examples

-   -   A person buys or rents a measurement instrument according to the        invention. There is an agreement that the family doctor will        receive a report from the Interactive Testing System twice a        year.    -   A person has been diagnosed with diabetes 2. There is an        agreement that the person measures blood and urine once a month.        The person will receive values of some selected parameters and        the family doctor receives the health report from the        Interactive Testing System.    -   A family doctor finds the health of one of his patients not be        quite in order. The person is asked to measure him- or herself        once a month and the health report sent to the doctor.

FIG. 6. Supervision of Health of People

The service is used to provide with recommendation on the personsmeasured.

Examples

A company hires a nurse to come twice a year to measure each staffmember. If special features are found, the company only wants to knowwhat is best for the person. If for instance, the person has beenstressed over longer period of time, and some effects are detected, thecompany wants instructions and recommendations for the person. If it maybe serious, the person may be asked to contact a health practitioner.The service may be mainly used to improve the lifestyle of the staffmembers.

Similarly, supervising the health of children at school, old peoples'home, ship crew, sports club members etc the main issue may be if thehealth is normal or not. If not the person may be advised to seek ahealth practitioner. But for instance a sports club may not beinterested in a connection to a health care provider.

FIG. 7. Only Significant Risks are Forwarded

It may be required only to forward a report, if there have been foundsignificant results.

Examples

A union of diabetes patients wants a report, if a significant trendtowards diabetes 2 has been detected.

A client arranges with a clinic for cardiovascular diseases that theclinic will receive the report from the Interactive Testing System, ifthere have been found some clear indications of some cardiovasculardiseases.

1. An interactive testing system for analysing biological samples, saidsystem comprising one or more remote measurement system(s) for measuringa biological sample, said remote measurement system generatingmeasurement data from the measurement of said biological sample, acentral server for processing said measurement data thereby generatingmeasurement values and/or profiles, wherein said central servercomprises two databases, one database comprises reference values fordiseases, means for allowing said remote measurement system tocommunicate with the central server over a network, in said remotemeasurement system means for forwarding measurement data from the remotemeasurement system to the central server through the network, and adisplay unit, in said central server means for generating a healthprofile from said measurement values, means for storing said measurementvalues, means for processing measurement data into patterns forcomparison with references for one or more diseases, and means forforwarding said health profile from said central server to the displayunit in the remote system.
 2. The interactive testing system accordingto claim 1, wherein said central server comprises means for generating ahealth report from statistical analysis of said measurement values,means for storing said health report, and means for forwarding saidhealth report from said central server to a health care provider.
 3. Theinteractive testing system according to claim 1, wherein the healthprofile comprises an early warning for a disease.
 4. The interactivetesting system according to claim 1, wherein the remote measurementsystem comprises a measurement instrument, wherein said measurementinstrument includes the means for forwarding the measurement data. 5.The interactive testing system according to claim 1, wherein the remotemeasurement system comprises one or more measurement instrument(s), eachbeing connected to a computer, wherein said computer includes the meansfor forwarding the measurement data.
 6. The interactive testing systemaccording to claim 1, wherein the measurement data consists of spectraldata.
 7. The interactive testing system according to claim 1, whereinthe central server comprises a central database for storing actual andhistorical measurement values for each remote user.
 8. The interactivetesting system according to claim 1, wherein the central servercomprises normal population ranges for each measurement value provided.9. The interactive testing system according to claim 1, wherein thehealth profile includes a comparison of measurement values with normalpopulation values, and/or a comparison of measurement value withhistorical measurement values.
 10. The interactive testing systemaccording to claim 1, further providing means for enabling communicatingwith a health care provider.
 11. An interactive testing method foranalysing biological samples, said method comprising establishing one ormore remote measurement system(s) for measuring a biological sample,said remote measurement system generating measurement data from themeasurement of said biological sample, performing a measurement usingsaid remote measurement system obtaining measurement data, forwardingthe measurement data to a central server, said central server comprisingtwo databases, wherein one database comprises reference values for oneor more diseases, processing said measurement data thereby generatingmeasurement values and/or profiles, processing measurement data intopatterns for comparison with references for one or more diseases,generating, in said central server, a health profile from saidmeasurement values, and storing said measurement values, and forwardingsaid health profile from said central server to the remote system, anddisplaying the health profile.
 12. The interactive testing methodaccording to claim 11, wherein the measurement data consists of spectraldata.
 13. The interactive testing method according to claim 11, whereinthe health profile includes a comparison of measurement values withnormal population values, and/or a comparison of measurement value withhistorical measurement values.